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College of Medicine
Departments / Psychiatry and Behavioral Neuroscience / Research / Clinical Research / Clinical Research Management (CRM) / Trial Phases 1, 2 & 3 Defined
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Psychiatry and Behavioral Neuroscience
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Clinical Trials Phases Defined
Phase I
Phase I trials are concerned primarily with establishing a new drug's safety and dose range in about 20-100 healthy volunteers. How a drug is absorbed, distributed, metabolized and excreted by the human body is called Pharmacokinetics. This is determined through frequent blood draws (usually in an inpatient environment) to check for the level of drug in the blood plasma.
Pharmacokinetic trials are usually considered Phase I trials regardless of when they are conducted during a drug's development. Dosage range of a new drug is determined by administering increasingly larger doses to one or more groups of subjects, who are closely monitored for harmful side effects. The goal is to learn the maximum tolerated dose that does not produce unacceptable side effects.
Phase I studies may involve risks even though an investigational drug has passed the Preclinical phase of testing. Phase I studies typically offer little or no benefit to the volunteer subjects; therefore they typically are compensated for their time and effort. Although usually conducted with healthy volunteers, Phase I trials are sometimes conducted with severely or terminally ill patients, for example those with AIDS or cancer.
A Phase I trial takes several months to complete. About 70 percent of experimental drugs pass this initial phase of testing.
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